Welcome to our dedicated page for Dynavax Technolo news (Ticker: DVAX), a resource for investors and traders seeking the latest updates and insights on Dynavax Technolo stock.
Dynavax Technologies Corporation (Nasdaq: DVAX) generates a steady flow of news as a commercial-stage biopharmaceutical company focused on vaccines for infectious diseases. News coverage commonly highlights developments related to its adult hepatitis B vaccine HEPLISAV-B®, its CpG 1018® adjuvant platform, and a growing pipeline of adjuvanted vaccine candidates.
Investors and observers following DVAX news will see regular updates on financial results, including quarterly earnings releases filed via Form 8-K, where Dynavax reports HEPLISAV-B net product revenue, total revenues, and adjusted EBITDA, along with commentary on market share trends in the U.S. adult hepatitis B vaccine market. These releases often include forward-looking guidance and discussion of capital allocation decisions such as share repurchase authorizations.
Another major category of Dynavax news involves clinical and pipeline milestones. The company issues press releases on topline data from its Phase 1/2 shingles vaccine trial for Z-1018, describing immunogenicity, tolerability and head-to-head comparisons with Shingrix®. Additional updates cover progress in its plague vaccine program funded by the U.S. Department of Defense, its pandemic influenza adjuvant program using CpG 1018 with H5N1 influenza vaccine, and its investigational Lyme disease vaccine candidate.
Corporate and strategic news items include participation in healthcare investor conferences, announcements of conference calls and webcasts, and collaboration agreements. Notably, Dynavax and Vaxart announced an exclusive license and collaboration for an investigational oral COVID-19 vaccine candidate, and Sanofi has announced an agreement to acquire Dynavax through a cash tender offer and subsequent merger, subject to customary conditions.
By tracking the DVAX news feed, readers can monitor how Dynavax’s commercial performance, clinical data, collaborations and corporate transactions evolve over time. This page aggregates company press releases and related disclosures so that users can review financial updates, pipeline progress and strategic announcements in one place.
Dynavax Technologies Corporation (Nasdaq: DVAX) announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for HEPLISAV-B, recommending marketing authorization for this hepatitis B vaccine in adults 18 and older. The recommendation is based on favorable safety and immunogenicity data from three Phase 3 trials. If approved by the European Commission in early 2021, HEPLISAV-B will enhance patient compliance with its two-dose regimen, addressing significant challenges in hepatitis B vaccination.
Clover Biopharmaceuticals has reported positive Phase 1 clinical trial results for its COVID-19 S-Trimer vaccine candidates, demonstrating strong immune responses and a favorable safety profile in 150 participants. Both GSK and Dynavax adjuvants showed 100% seroconversion for neutralizing antibodies in adult groups. The vaccine's stability allows for storage at refrigeration temperatures, facilitating global distribution. Clover plans to begin Phase 2/3 efficacy studies in December 2020 and initiate a pivotal trial with Dynavax in early 2021, aiming to produce over one billion doses annually.
Dynavax Technologies Corporation (NASDAQ: DVAX) will have CEO Ryan Spencer participate in a virtual fireside chat at the 3rd Annual Evercore Virtual ISI HealthCONx Conference on December 3, 2020, at 10:05 a.m. E.T. The event will be accessible via the company's website under the 'Events & Presentations' section. A replay will be available for 30 days post-event. Dynavax is developing innovative vaccines, including its first commercial product, HEPLISAV-B, aimed at preventing hepatitis B infections in adults.
Biological E. Limited, in partnership with Dynavax Technologies and Baylor College of Medicine, has initiated a Phase I/II clinical trial for its COVID-19 subunit vaccine candidate in India, receiving approval from the Drugs Controller General of India. The trial will involve approximately 360 healthy participants aged 18 to 65, evaluating the vaccine's safety and immunogenicity using an antigen from BCM Ventures and Dynavax's adjuvant CpG 1018. Results are anticipated by February 2021, marking a significant step in addressing the COVID-19 pandemic with a safe and affordable vaccine.
Dynavax Technologies Corporation (Nasdaq: DVAX) reported third-quarter 2020 results, with HEPLISAV-B product revenue at $11.6 million, a rise from $10.2 million in 2019. The company highlighted a rebound in the adult hepatitis B vaccine market, achieving a 23% market share. Agreements with Valneva could yield $130 to $230 million in 2021 for its adjuvant, CpG 1018. Research and development expenses decreased to $8.5 million, while SG&A expenses rose to $21.5 million. Net income was $4.4 million, influenced by a $21.2 million gain in warrant liability.
Dynavax Technologies Corporation (NASDAQ: DVAX), a biopharmaceutical firm focusing on vaccine development, announced that CEO Ryan Spencer will present at the Stifel 2020 Virtual Healthcare Conference on November 16 at 3:30 p.m. E.T. Investors can access the live audio webcast via the 'Events & Presentations' section on the company's website. A replay will be available for 30 days after the event. Dynavax's HEPLISAV-B® vaccine is approved for preventing hepatitis B in adults and is advancing its CpG 1018 vaccine adjuvant through various collaborations.
Dynavax Technologies Corporation (Nasdaq: DVAX) will report its third quarter 2020 financial results on November 5, 2020, after U.S. markets close. A conference call with live audio webcast is scheduled at 4:30 p.m. ET. The company is known for developing novel vaccines, including HEPLISAV-B®, a hepatitis B vaccine. Further developments include collaborations on adjuvanted vaccines targeting COVID-19 and influenza. For detailed information, visit www.dynavax.com.
Dynavax Technologies (DVAX) announced that Medigen Vaccine Biologics Corporation (MVC) received a Taiwan government subsidy of NT$ 472 million (US$ 16.4 million) for initiating a Phase 1 clinical trial of a COVID-19 vaccine. The trial, which started in early October, aims to evaluate the safety and immunogenicity of MVC's vaccine combined with Dynavax's CpG 1018 adjuvant. The study involves around 45 healthy participants, receiving two doses 28 days apart, demonstrating the potential for enhanced immune response against COVID-19.
Dynavax Technologies Corporation (NASDAQ: DVAX) announced the appointment of Peter R. Paradiso, Ph.D., to its Board of Directors on September 24, 2020. With over 30 years of expertise in vaccine strategic planning, Paradiso is set to provide valuable guidance as the company expands its vaccine portfolio, particularly focusing on HEPLISAV-B and CpG 1018. Concurrently, Michael Ostrach, CFO and CBO, has announced his retirement planned for 2021. Dynavax will seek a successor while Ostrach continues until March 31, 2021, to ensure a smooth transition.
Valneva SE and Dynavax Technologies Corporation have formed a commercial partnership for the supply of Dynavax's CpG 1018 adjuvant to be used in Valneva's COVID-19 vaccine candidate, VLA2001. The UK government has agreed to purchase up to 190 million doses of VLA2001 over five years. Dynavax will supply the adjuvant necessary for 100 million doses in 2021, with an option for an additional 90 million doses by 2025. VLA2001 is expected to enter clinical studies by the end of 2020 and aims for regulatory approval in the second half of 2021.